As the end of the month draws to a close, here’s a summary of some of the more important regulatory news stories from March.
CDC Releases Long Awaited Opioid Guideline
The Centers for Disease Control (CDC) released its long awaited Opioid Guidelines. The guidelines are geared toward primary care providers who are treating patients for chronic pain not related to cancer and patients who are undergoing end of life care. The guidelines include 12 recommendations that the CDC said are based on three key principles: (1) Non-opioid therapy is preferred for chronic pain outside of active cancer, palliative and end of life care. (2) When opioids are used, the lowest possible effective dosage should be prescribed to reduce risks of opioid overdose. (3) Providers should always exercise caution when prescribing opioids and monitor all patients closely.
Dr. Andrew Kolodny, director of Physicians for Responsible Opioid Prescribing (PROP), said the CDC did a good job of resisting efforts to weaken the guidelines. He stated, “These recommendations are going to be taken seriously.”
Supreme Court of Oklahoma Rules Part of Opt Out Law Unconstitutional
The Supreme Court of Oklahoma has weighed in on part of the new Injury Benefit Act (Opt Out law) passed in 2013. Their decision in Torres v. Seaboard Foods says that the portion of the Injury Benefit Act that bars cumulative trauma (CT) injury claims that occur in the first 180 days of employment is unconstitutional.
As some background, the reason the Oklahoma legislature included the 180-day bar on CT claims was to fight fraud. This is because the vast majority of legitimate CT related claims take place after the employee has been on the job several years. In fact, it is extremely rare that an employee will have a valid CT claim within the first year of employment.
However, the Supreme Court said this portion of the law violates equal protection, and is unconstitutional. Specifically, the Supreme Court said that the statute was under-inclusive because it fails to include employees actually suffering CT injuries in the first 180 days. If the IW actually suffers a CT injury in the first 180 days, that IW is left without a remedy because they can neither get workers’ comp benefits nor sue in tort for causes of action such as employer negligence or strict liability.
The injured worker, Yaumary Torres, will now have her case heard by an OK Workers’ Comp Commission Administrative Law Judge (ALJ). That ALJ will simply apply regular workers’ comp laws.
Mass. Governor Charlie Baker Signs Bill Limiting Opioid Prescriptions
House Bill 4056 creates the first law in the nation limiting an initial opioid prescription to a seven day supply. Doctors would be allowed to prescribe opioids for more than seven days to treat chronic pain, cancer pain, or palliative care. But to do so they would need to note in the medical record the reason why a greater supply of opioids is needed. The bill would also require doctors to consult the state’s prescription drug monitoring database (PDMP) before writing a prescription for a Schedule II or III narcotic.
FDA Adds Warning Labels To Immediate-Release Opioids
A new boxed warning will be included with immediate-release opioids. In addition, all opioid drugs will come with expanded safety information under new requirements. The warning will be a “black box” warning, similar to what you see on extended-release opioids. It will caution prescribers and patients about the serious risks of misuse, abuse, addiction, overdose and death.
Prium President Michael Gavin expressed doubts that the labeling would do much to change prescriber behavior – including off-label use. But the warnings may prompt additional conversations between pharmacists and patients. “Absolutely the pharmacist should be having different conversations with patients now.”
Louisiana Takes First Step Toward Creating a Drug Formulary
Louisiana has introduced HB 725. This bill would mandate the creation of a workers’ comp drug formulary. The formulary would work in a similar manner to the ODG-based Texas formulary. The Texas formulary, which has become a model for many states, allows an injured worker to receive an approved drug without prior approval. Any drug not on the list must be approved on a case-by-case basis.